Advocacy Update

• CAP Urges CMS to Improve Medicare Payment and Reduce Quality Program Burdens on Pathologists
• CAP Advocacy Win: UnitedHealthcare to Indefinitely Delay Requirements for Z-Codes
• Pathologists Feedback Wanted on MIPS Payment Penalty Experiences
• CAP Releases Evidence-Based Guidance for Processing Products of Conception Specimens
• State Advocacy Win: Washington State Pathologists, CAP Continue to Deter Move to Federal IDR System
• CDC Ends Mpox Public Health Emergency, Lab Reporting Requirements Change
• Take Our News Quiz for September

In its formal comments to the Centers for Medicare & Medicaid Services (CMS), the CAP urged the federal agency to stop Medicare cuts to pathologists next year, make the Merit-based Incentive Payment System (MIPS) less taxing on pathologists, and maintain remote sign-out capabilities for pathologists under CLIA. The CMS published the 2024 proposed Medicare Physician Fee Schedule, Quality Payment Program (QPP) regulation and a request for information regarding CLIA regulations on July 13. The CAP responded to the proposed regulation with a 25-page letter on September 11 that advocated for several changes that would protect the value of pathology services and reduce regulatory burden on pathologists.

Improve Medicare Payment to Pathologists

The CAP comments included recommendations to improve and protect the value of pathology services by updating Medicare’s data used to calculate physician fee schedule payments for both pathology services and the physician fee schedule as a whole.

The CAP also expressed opposition for the CMS to implement a new evaluation and management (E/M) add-on code, G2211, for ongoing, longitudinal patient care, as the extra service will be heavily utilized causing overall rate cuts to Medicare’s fee schedule. In the letter, the CAP called on the CMS to discard payment of G2211 as the work in the add-on code is already described and accounted for within the existing E/M code set. Implementation of G2211 would essentially mandate duplicate billing of physician services.

Proposed 2024 MIPS Reporting for Pathologists

Though limited, the proposed changes to the MIPS program could have a significant impact on pathologists’ scores and payment bonuses, the CAP stated to the CMS.

In 2024, pathologists reporting MIPS will have to act to avoid penalties that reduce future Medicare Part B payments for their services. Failing to reach the scoring threshold in 2024 could result in Medicare payment penalties up to 9% in 2026.

With the proposed 2024 increase in performance threshold to stop penalties, it is likely that many small practices –especially those that rely heavily on the topped out QPP measures-- could see a reduction in their MIPS performance scores and be penalized. Billing companies alone are not able to avoid this problem for practices. In the letter, the CAP urged the CMS to make MIPS less burdensome for pathologists and to create measures to increase pathologists’ opportunities to demonstrate the quality they provide so they can score well in the program.

CLIA Request for Information on Remote Sign-Out and More

Finally, the proposed physician fee schedule included a request for information on histopathology, cytology, and clinical cytogenetics regulations under CLIA to achieve the following objectives:

• Developing regulations around slide staining and tissue processing as a part of the wider CLIA regulations and certification
• Making the public health emergency enforcement discretion permanent to allow pathologists to review slides remotely
• Making the public health emergency enforcement discretion permanent that allows for cytogeneticists to review images remotely

In the letter, the CAP recommended CLIA modernization focus on where practice and technology necessitates updates to CLIA regulations. The CAP also supported CLIA regulations to allow for remote viewing and sign out of digital slides, while establishing appropriate controls to ensure patient safety and clinical quality.

The CAP and UnitedHealthcare had a meeting on August 3, to discuss the planned update to the insurer’s molecular pathology policy, professional and facility reimbursement, previously announced on May 1, 2023.

Following the meeting, UnitedHealthcare made the decision to delay the new molecular pathology policy to ensure that those providers who have not yet taken steps to register applicable tests or have not yet completed the registration process have additional time to do so and to receive Z-codes for use in submitting claims. They will announce the new effective date prior to publication of the policy. In advance of the new effective date, providers are encouraged to begin submitting Z-codes on their claims.

Claims will not be denied if they do not contain a Z-code. However, continued submission of the Z-codes will provide time to ensure compliance when the policy goes into effect and may lead to fewer requests for information. To be prepared for the policy’s publication, providers should continue to register their Phase 1 tests and complete the steps to obtain a Z-code. Providers who have questions or need assistance should email united_genetics@uhc.com.

UnitedHealthcare said in a letter to the CAP, “We value your engagement and appreciate your partnership as we strive toward our shared missions of improving healthcare delivery. We appreciate the opportunity to discuss the policy and our reasoning for requesting providers submit Z-codes for the molecular diagnostic tests they perform. We also value the resulting dialogue.”

The CAP is asking its members for details about their own experiences with payment penalties and positive adjustments from Medicare’s Merit-based Incentive Payment System (MIPS). Compiling this information is crucial to understand the scope of the MIPS payment adjustment in 2024 for the CAP’s advocacy efforts to stop physician fee schedule payment cuts.

On August 10, the Centers for Medicare & Medicaid Services (CMS) made available 2022 MIPS performance feedback, which determines whether physicians will receive a positive, neutral, or negative payment adjustment on Medicare services furnished in 2024. Pathologists can view this information on the Quality Payment Program (QPP) website using their HCQIS Access Role and Profile (HARP) credentials. The CMS Payment Adjustment User Guide details the process of accessing and downloading performance feedback.

We encourage you to view this information as soon as possible. If there are any errors, you should consider submitting an appeal, also called a targeted review. The deadline to submit a targeted review is October 9, 2023. For more information about how to request a targeted review, please refer to the 2022 Targeted Review User Guide.

If you feel comfortable, we request that you share de-identified score and corresponding payment adjustment information with the CAP. This will inform our understanding of the impact of MIPS on physician payment in 2024 and can help us in our conversations with the Administration and Congress about ensuring physician payment supports high-quality care to Medicare patients. Please share your information by emailing us mips@cap.org.

The CAP has released a “Products of Conception Guidance Document” as a resource for pathologists on the evidence-based best practices for processing and reporting of pregnancy tissues/products of conception (POC) specimens. This guidance addresses evidence-based best practices related to which POC specimens are exempted from pathologic evaluation, which specimens can be evaluated by a pathologist with a gross-only examination, as well as other POC-related issues. In addition, the guidance addresses important reporting considerations related to POC and fetal tissue specimens.

“It's important to note that this guidance addresses issues that pathologists may face but does not convey legal advice,” said CAP President Emily E. Volk, MD, FCAP. “The law surrounding abortion is changing rapidly and the law varies from state to state. “As such, it is critical that pathologists consult with legal counsel whenever they are uncertain as to the law on an abortion-related issue,” she added.

The Washington State Pathology Society (WSSP), in collaboration with the CAP, and the Washington State Medical Association (WSMA), successfully retained Washington state’s balance billing dispute resolution process, and further delaying any referral to the federal independent dispute resolution system until at least July 1, 2024.

Previously, the Washington State Office of the Insurance Commissioner released the decision to delay the transition to the federal No Surprises Act independent dispute resolution process (IDR) in late 2022. The WSSP, the CAP, and the WMSA opposed legislative changes, since enacted, to supplant the current state’s arbitration process with the federal IDR system.

On August 3, WSSP and WMSA submitted comments in response to Office of the Insurance Commissioner’s request for information to maintain the state arbitration system under the Balance Billing Protection Act until at least July 1, 2024.

In Office of the Insurance Commissioner’s communications, it noted the delay to the federal IDR system was due in part to the ruling in Texas Medical Association, et al. v. United States Department of Health and Human Services—after which the federal No Surprises Act’s IDR process was temporarily paused and longer accepted newly initiated disputes. Currently, there is no information as to when the system will resume.

In the months ahead, the Office of the Insurance Commissioner will provide an update on or before March 1, 2024, on its decision to have Washington state transition to the federal IDR system.

On August 31, the Centers for Disease Control and Prevention (CDC) ended its public health response to the 2022 Mpox Outbreak. CDC’s Division of Select Agents and Toxins (DSAT) posted a Select Agent (SA) Gram to inform clinical and diagnostic laboratories and other entities that the standard (pre-October 4, 2022) reporting requirements for the identification of Mpox virus will be reinstated on October 30, 2023.

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